The Link Between Anemia and Deficits in Memory and Attention in Individuals With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

Sickle-Cell Disease: Neuroimaging and Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451919
• Other study ID #: 375
• Secondary ID: K01HL073152
• Status: Completed
• Phase: N/A
• First received: March 23, 2007
• Last updated: August 18, 2016
• Start date: July 2006
• Est. completion date: February 2009

Study information

• Verified date: October 2013
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Sickle cell disease is an inherited blood disorder that affects red blood cells (RBCs). People with sickle cell disease frequently experience anemia, or a low number of RBCs. RBCs are responsible for carrying oxygen to the brain and other body tissues that need oxygen to function properly. The purpose of this study is to determine what changes, which were possibly caused by anemia, exist in the brains of individuals with sickle cell disease.

Description:

The role of RBCs is to carry oxygen from the lungs to the brain and other body tissues. Individuals with anemia have unusually low numbers of RBCs. They also often have difficulty concentrating and remembering information, which is likely caused by a reduced oxygen supply to the brain. Previous research has shown that correcting anemia in patients without sickle cell disease improved their memory and attention. The purpose of this study is to examine any abnormal changes in the brains of individuals with sickle cell disease and to determine whether these changes are related to reduced memory and attention capabilities.

Participants will attend one study visit. During this visit, a brain magnetic resonance image (MRI) will be performed while participants complete neuropsychological tests that measure memory, attention, and organizational ability. There will be no follow-up visits.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of sickle cell disease

Exclusion Criteria:

• Pregnancy

• Claustrophobia

• Mass lesion (e.g., meningioma, cyst, or spinal block)

• Need for life support constant monitoring

• Any unstable condition that is likely to require resuscitation

• Presence of a pacemaker or other iron-containing magnetic substances in the body

Study Design

N/A

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)	University of California, San Francisco

Country where clinical trial is conducted

United States,